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| Dockets Entered
On April 9, 2007
Table of Contents
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| Docket #
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| Title
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| 1978N-0224
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| Trimethobenzamide Hydrochloride Suppositories
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| 2006D-0504
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| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0104
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| Medical Devices; Technical Amendment
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| 2007P-0134
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| ANDA Suitability for Hydrocodone Bitrartrate and Homatropine Methylbroomide Tablets, 2.5 mg / 0.75 mg
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| 1978N-0224
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| Trimethobenzamide Hydrochloride Suppositories
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| NWL
2
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| FDA
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| LET 4
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| Coalition for Mercury Free Drugs
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| Vol #:
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| 4
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| C 1
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| C Hart
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| EC 1885
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| Mrs. Suzette Benson
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| Vol #:
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| 31
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| EC 1886
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| Mrs. Tammy Flaherty
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| Vol #:
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| 31
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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| WDL 1
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| RS Medical
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| Vol #:
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| 7
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| 2006D-0504
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| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
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| C 8
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| GE Healthcare
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| Vol #:
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| 1
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| 2006P-0405
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| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
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| LET 1
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| FDA/CDER to UCB Inc
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| Vol #:
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| 2
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| LET 1
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| FDA/CDER to MedImmune Oncology Inc
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| Vol #:
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| 1
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| C 58
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| S Yerman
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| Vol #:
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| 6
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| 2006P-0535
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| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
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| LET 3
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| CoMed, Coalition for Mercury-Free Drugs
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| Vol #:
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| 2
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| C 1
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| Affiliated Computer Services Inc (ACS)
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| Vol #:
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| 6
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| EAPE 1
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| Chen, James
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| Vol #:
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| 1
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| EAPE 293
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| Chen, James
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| Vol #:
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| 1
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| EC 2
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| Dr. Beverly Warden
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| Vol #:
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| 6
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| EC 3
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| Verispan, LLC
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| Vol #:
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| 6
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| EC 4
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| Accenture
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| Vol #:
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| 6
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| EC 5
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 6
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| EC 6
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| Amylin Pharmaceuticals, Inc.
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| Vol #:
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| 6
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| EC 7
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 6
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| EC 8
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| CRIX International
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| Vol #:
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| 6
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| 2007N-0104
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| Medical Devices; Technical Amendment
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| | | | | | | | |
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| EAPE 23
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| Richesson, Cathleen
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| Vol #:
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| 1
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| EAPE 24
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| Hobbs, Nielsen
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| Vol #:
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| 1
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| EAPE 25
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| Cohen, D. Bruce
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| Vol #:
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| 1
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| EAPE 26
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| Cook, Rosemary
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| Vol #:
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| 1
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| EAPE 27
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| Rawson, Pearl
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| NHC
1
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| FDA
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| Vol #:
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| 1
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| 2007N-0123
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| Amlodipine Abbreviated New Drug Application Approvals
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| EMC 8
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| Synthon Pharmaceutical Inc.
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| Vol #:
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| 2
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| 2007P-0085
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| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
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| C 4
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| Blommer Chocolate company
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| Vol #:
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| 2
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| C 5
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| M Smylie
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| Vol #:
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| 2
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| EC 2
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| Don't Mess with Our Chocolate
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| Vol #:
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| 3
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| EC 3
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| Mr. William Campbell
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| Vol #:
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| 3
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| EC 4
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 5
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| Haymarket Group Ltd.
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| Vol #:
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| 3
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| EC 6
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| Mrs. Irina Ioshpe
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| Vol #:
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| 3
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| EC 7
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| Mr. Julian Ioshpe
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| Vol #:
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| 3
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| EC 8
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| Mr. Aaron Ioshpe
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| Vol #:
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| 3
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| EC 9
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| Mr. Leo Ioshpe
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| Vol #:
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| 3
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| EC 10
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| Mrs. Zinaida Rabinovich
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| Vol #:
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| 3
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| EC 11
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| Mr. Anatoliy Brenman
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| Vol #:
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| 3
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| EC 12
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| Mrs. Oksana Cherniy
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| Vol #:
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| 3
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| EC 13
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| Mr. Andrey Cherniy
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| Vol #:
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| 3
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| EC 14
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| Mr. Yuriy Cherniy
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| Vol #:
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| 3
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| EC 15
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| Mr. Max Cherniy
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| Vol #:
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| 3
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| EC 16
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| Mrs. maureen elitzak
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| Vol #:
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| 3
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| EC 17
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| Ms. Linda Grishman
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| Vol #:
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| 3
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| EC 18
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| Mrs. Gayle Johnson
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| Vol #:
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| 3
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| EC 19
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| Ms. Heidi Cinicolo
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| Vol #:
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| 3
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| EC 20
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| Don't Mess With Our Chocolate
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| Vol #:
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| 3
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| EC 21
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| Sweet Paradise Chocolatier
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| Vol #:
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| 3
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| EC 22
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| Ms. Robyn Rice-Foster
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| Vol #:
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| 3
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| EC 23
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| Ms. Shelley Fields
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| Vol #:
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| 3
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